Benzinga · Feb 24, 2022
The Daily Biotech Pulse: Orphazyme Plunges On Regulatory Setback In Europe, Pulmonx Earnings Disappoint, Amicus Declines To Spin Off Genetic Medicine Company
Here's a roundup of top developments in the biotech space over the last 24 hours: Stocks In Focus Adagio Appoints COO David Hering As Interim CEO Adagio Therapeutics, Inc., (NASDAQ: ADGI) announced that its board has appointed David Hering as interim chief executive officer, effective immediately. Hering's appointment came following the resignation of Tillman Gerngross as CEO. The interim CEO will retain his role as chief operating officer. Adagio also said It has initiated a formal CEO search and plan to appoint an executive with proven experience in bringing products to market and scaling operations. Orphazyme Says EMA Committee Leaning Against Approval Of Arimoclomol Orphazyme A/S (NASDAQ: ORPH) said it has been notified by the European Medicines Agency's Committee for Medicinal Products for Human Use of a negative trend vote on marketing authorization application for its investigational product candidate, arimoclomol, for the treatment of Niemann-Pick disease type C. The trend vote indicates that the CHMP's current orientation is to not approve arimoclomol when it convenes by the end of March 2022, Orphazyme said. In the light of the development and its financial situation, it said it will now assess its strategic options and provide an update to the market at the applicable time. The U.S. Food and Drug Administration had rejected Orpahzyme's new drug application for arimoclomol in June 2021. The stock was plunging 22.28% to $1.57 in premarket trading. Grifols Announces R&D Collaboration For Antithrombin III Therapy In Sepsis Grifols NASDAQ: GRFS) announced a collaboration with Endpoint Health, Inc., a precision medicine company, to develop and commercialize an Antithrombin III therapy to treat sepsis. As part of the collaboration, and subject to the FDA's acceptance of a proposed investigational new drug and investigational device exemption filings, Endpoint Health will deploy its AI technology and its proprietary diagnostic test in a phase 2 trial designed to identify septic patients mostly likely to respond to AT-III. Upon FDA approval, the companies will invest in a build-out of AT-III production at Grifols sites. Related Link: The Week Ahead In Biotech (Feb. 20-26): Reata Awaits FDA Decision, Bausch Health, Moderna Lead Earnings News Flow Amicus Terminates SPAC Deal to Spinoff Genetic Medicine Company ARYA Sciences Acquisition Corp IV (NASDAQ: ARYD), a SPAC sponsored by Perceptive Advisors, announced that, due to existing market conditions, it has mutually agreed with Amicus Therapeutics, Inc. (NASDAQ: FOLD) to terminate their previously announced business ...
